It’s impossible to know exactly what future trends will influence the direction and methodologies of quality assurance (QA). However, according to Bristol Myers Squibb executive Donna Gulbrinski, looking at how quality professionals overcome current challenges can lend some insight on future QA strategies and processes.
Gulbrinski was one of the presenters at the 2016 PDA/FDA Joint Regulatory Conference held in Washington, D.C. In her comments, Gulbrinski identified some strategies for how your quality management practices should function going forward.
In her presentation titled “Today’s Challenges to Quality and Future Opportunities,” Gulbrinski noted that there is no shortage of challenges with quality assurance in product development and change is probably the biggest nuisance. Ongoing changes to regulatory guidelines and manufacturing technologies will likely introduce obstacles that we have yet to experience. She asserted that in order to keep combating new issues, you should change the lens you currently use to view the world of quality.
If you are a regulated company like a pharmaceutical or medical device manufacturer, you’re well aware that your industry continually changes. Your quality assurance methods may be sufficient now, but will that always be the case going forward? Gulbrinski recommended that regulated industries explore more of a collective strategy by establishing a culture of quality. “You will only get so far – until you address the culture,” she said.
So what does a culture of quality look like? Gulbrinski said it’s ultimately about getting people to act. To win in quality, adopt these three principles as a foundation for your initiatives.
It’s a common belief that seasoned ship captains are keenly aware of every crew member, every function, every nut and every bolt on their vessels. Company leaders should be just as cognizant of their operations. Leadership is engaged, sets the tone and articulates the aligned vision and expectations. Senior management “walk throughs” nurture an environment of transparency, trust and the pursuit of continuous improvement.
It will be easier for organizational leaders to engage in building a culture of quality when they see the inherent value that comes with this approach. Quality assurance processes that are woven into product design and all manufacturing phases reduce errors, which means there is less time and money spent correcting mistakes and repeating tasks. Depending on the size of your organization, the annual cost savings could reach into the millions.
To develop a culture of quality, you must foster an agile mindset throughout the organization. Approaches to quality are evolving and your organization needs to keep pace with the changes. If you view quality as a safety net or a requirement for compliance, you should consider taking more of a predictive approach. The ability to foresee changes and potential setbacks that occur due to variabilities in product development processes and materials will help you alleviate surprises and costly oversights.
In order to stay current or even a step ahead of the frequently changing regulatory landscape, there needs to be an attitude of continuous improvement throughout your organization. Operational excellence means that quality needs to be mobilized early in the product design stage and it should have its own set of metrics in every phase of manufacturing.
A culture of quality means that every employee has the same vision of quality and understands where his or her contribution fits in that vision. The focus is on the product. Everyone has an end-to-end view of all products, processes and methods, and there is a free flow of communication, data and information throughout the supply chain.
This holistic approach to quality will help keep your employees sharp and able to make necessary adjustments faster. This is how you can better control variabilities, drive right-the-first-time performance and achieve a higher level of product reliability.
Gulbrinski said you will only get so far until you address the culture. How do you envision a culture of quality? Please comment below.
David Jensen is a marketing communication specialist at MasterControl. He has been writing technical, marketing and public relations content in technology, professional development, business and regulated environments for more than two decades. He has a bachelor’s degree in communications from Weber State University and a master’s degree in professional communication from Westminster College.
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